[Federal Register Volume 60, Number 38 (Monday, February 27, 1995)]
[Notices]
[Pages 10592-10593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4766]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94D-0386]
Revised FDA Form 3210 Application for Establishment License for
Manufacture of Biological Products (4/94); Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the revised FDA Form 3210 Application for Establishment
License for Manufacture of Biological Products (4/94). This form
replaces the previous edition of FDA Form 3210 (12/88). FDA Form 3210
is used by manufacturers to apply for licensure of a facility for the
manufacture of biological products regulated under the Public Health
Service Act. The form has been revised because of inadequacies in the
previous form that resulted in requests by the agency for supplemental
information. The revised form is intended to shorten review time and
decrease expenditure of resources for both the agency and industry.
DATES: FDA will continue to accept submissions using the previous Form
3210 (12/88) until August 28, 1995.
FOR FURTHER INFORMATION CONTACT: Timothy W. Beth, Center for Biologics
Evaluation and Research (HFM-635), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448, 301-594-3074.
ADDRESSES: Submit written requests for single copies of the revised FDA
Form 3210 Application for Establishment License for Manufacture of
Biological Products (4/94) to Division of Congressional and Public
Affairs (HFM-11), Center for Biologics Evaluation and Research (CBER),
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-
1448, 301-594-1800. Requests should be identified with the docket
number found in brackets in the heading of this document. Send two
self-addressed adhesive labels to assist that office in processing your
requests. The form may also be obtained by calling the CBER FAX
Information System at 301-594-1939 from a FAX machine with a touch tone
phone attached or built in. FDA Form 3210 Application for Establishment
License for Manufacture of Biological Products (4/94) is available for
public examination in the Dockets Managements Branch (HFA-305), Food
and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD
20857, between 9 a.m. and 4 p.m., Monday through Friday.
SUPPLEMENTARY INFORMATION: FDA is making available revised FDA Form
3210 Application for Establishment License for Manufacture of
Biological Products (4/94). The form was revised due to inadequacies in
the old form which made the application review process cumbersome and
difficult for both the agency and industry. In the past, the review
process was often significantly lengthened because of requests by the
agency for supplemental information from the manufacturer in order to
ensure the safety, purity, potency, and efficacy of manufactured
biological products. The revised form details more specifically the
information that is required for establishment licensure. FDA believes
that the revised form will expedite the review process by reducing the
need for supplemental information requests and responses.
The revised form solicits information from the manufacturer in the
following areas: (1) General information (names and addresses); (2)
water systems; (3) heating ventilation and air conditioning systems;
(4) raw materials and ancillary facilities; (5) source materials; (6)
propagation of host systems; (7) intermediate processing; (8)
formulation and final product preparation; (9) computer systems; (10)
support areas; (11) quality control areas; (12) animal facilities for
testing; (13) animal facilities for production; (14) calibration and
validation; and (15) records.
In addition, the revised form also requires the following
information to be submitted: A description of the lot numbering system,
an organizational chart, an environmental assessment report, written
agreements, curriculum vitae for key manufacturing and responsible
personnel, and an overview of the current good manufacturing practices
(CGMP) training program. A comments section is provided on the revised
form for additional information that the manufacturer deems to be
appropriate but may not be covered under other sections.
Manufacturers preparing to submit applications for establishment
licensure should now utilize the revised (4/94) form. FDA will continue
to accept submissions using the previous (12/88) form until August 28,
1995. Because the old form does not address specific questions and
issues that are present on the revised form, additional review cycles
should be anticipated when using the previous form.
Under the Paperwork Reduction Act of 1980 (Pub. L. 96-511) all
forms requesting a collection of information [[Page 10593]] on
identical items from 10 or more public respondents must be approved by
the Office of Management and Budget (OMB) and must display a valid OMB
control number and expiration date.
In accordance with the Paperwork Reduction Act, in the Federal
Register of February 4, 1994 (59 FR 5436), a notice announced the
proposed revision of FDA Form 3210 Application For Establishment
License for Manufacture of Biological Products. OMB approval for the
revised FDA Form 3210 was obtained on April 30, 1994, and given OMB
approval number 0910-0124; expiration date April 30, 1997.
Dated: February 17, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-4766 Filed 2-24-95; 8:45 am]
BILLING CODE 4160-01-F